Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Institut Paoli-Calmettes
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01499537
First received: September 16, 2011
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD) is the most commonly used alternative, surgery having higher morbidity and mortality rates, unacceptable especially in palliative situation. Recent developments in interventional endoscopic ultrasonography (EUS) allow new endoluminal approaches to pancreatic-biliary structures, such as cysto-enterostomy or pancreatic-enterostomy. More recently were described the possibility to realize EUS-guided biliary drainage, through the duodenal or the gastric wall. Advantages of the EUS-guided approach are to be realizable even the papilla is not suitable endoscopically (duodenal stricture or post-surgical status) and to allow if necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). This technique is actually an alternative to PTBD. In comparison of the PTBD, EUS-guided route seems to have less morbidity and to avoid external biliary drainage. Indeed, the morbidity rate of the percutaneous biliary drainage and the EUS-guided biliary drainage range respectively from 25 to 35% and from 0 to 23%. However, none study compare prospectively both techniques. Aims of this study are to compare the morbidity rate, feasibility and efficacy of these techniques.


Condition Intervention
Jaundice
Device: biliary drainage
Device: EUS guided biliary drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct in Patients With Malignant or Post-operative Jaundice After Failure or Impossibility to Perform Endoscopic Retrograde Cholangiography

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • Morbidity rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Morbidity rate during 30 post-operative days


Secondary Outcome Measures:
  • efficacy [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    decrease of bilirubine > 50%

  • feasibility [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
    succes or not of the intervention to obtain bilairy drainage

  • biliary drainage duration [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
    time between intervention and drain withdrawal

  • quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    QLQ-C30 questionnary at inclusion and at D30


Estimated Enrollment: 110
Study Start Date: January 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Percutaneous Drainage
Percutaneous Transhepatic Biliary Drainage (PTBD)
Device: biliary drainage
percutaneous transhepatic biliary drainage (PTBD)
Other Name: biliary drainage
Experimental: EUS-guided drainage
endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
Device: EUS guided biliary drainage
endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
Other Name: EUS guided biliary drainage

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >= 18
  • Karnofsky >= 50%
  • biliary stenosis (malignant or benign stricture)with failure of endoscopic retrograde cholangiopancreatography
  • signed informed consent

Exclusion Criteria:

  • isolated biliary stenosis of right hepatic canal
  • percutaneous biliary drainage < 10 days
  • laparotomy < 10 days
  • contra-indication to the procedure
  • pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499537

Contacts
Contact: Dominique GENRE, MD +33491223778 drci.up@ipc.unicancer.fr
Contact: Agnès BOYER CHAMMARD, MD +33491223778 drci.up@ipc.unicancer.fr

Locations
France
Institut Paoli-Calmettes Recruiting
Marseille, France, 13009
Contact: Agnes BOYER CHAMMARD, MD    +33491223778    drci.up@ipc.unicancer.fr   
Principal Investigator: Erwan BORIES, MD         
Hopital Nord Recruiting
Marseille, France, 13020
Contact: Marc BARTHET, MD PhD         
Principal Investigator: Marc BARTHET, MD PhD         
Monaco
Centre Hospitalier Princesse Grace Not yet recruiting
Monaco, Monaco, 98000
Contact: Jean-Marc DEMARQUAY, MD         
Principal Investigator: Jean-Marc DEMARQUAY, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Erwan BORIES, MD Institut Paoli-Calmettes
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01499537     History of Changes
Other Study ID Numbers: APHAGE/IPC 2010-002
Study First Received: September 16, 2011
Last Updated: October 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
Stenosis of biliary ways

Additional relevant MeSH terms:
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014